Brain & Muscle Stimulation for Stroke Rehabilitation

Overseen By David A Cunningham, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Must not be taking: Seizure medications

Disqualifiers: Neurological conditions, Seizure disorder, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help stroke patients improve control over their hand movements. It uses two types of non-invasive electrical stimulation, including transcranial direct current stimulation (tDCS), to assess their effects on hand motor control and brain activity. The trial includes different groups testing various combinations and timing of these stimulations. Suitable participants are those who had a stroke over six months ago, have some movement in their affected arm and hand, and can sit without support. If successful, this approach could provide new hope for better recovery after a stroke. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to innovative stroke recovery treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that lower the seizure threshold, as decided by the study physician.

What prior data suggests that this brain and muscle stimulation technique is safe for stroke rehabilitation?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for stroke patients. Only about 11.62% of studies have reported any side effects, which are typically mild, such as itching or a burning sensation. Studies indicate that tDCS, even at higher levels up to 4 mA, is well-tolerated.

This treatment has been tested alongside various therapies without causing significant problems. While caution is always important, current evidence suggests that tDCS is safe for use in stroke rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for stroke rehabilitation because they explore new ways to stimulate the brain and muscles, which could enhance recovery. Unlike traditional therapies that often focus solely on physical rehabilitation, these treatments use electrical stimulation to activate brain regions and muscles simultaneously. The unique use of transcranial direct current stimulation (tDCS) offers various configurations, such as conventional and unconventional electrode placements, to test different effects on the brain's lesioned hemisphere. This approach could provide insights into more effective rehabilitation techniques, potentially speeding up recovery for stroke survivors.

What evidence suggests that this trial's treatments could be effective for stroke rehabilitation?

Research has shown that transcranial direct current stimulation (tDCS) can improve brain function after a stroke. In this trial, participants will join different treatment arms to assess the effectiveness of tDCS combined with other therapies. Some studies suggest that tDCS, especially when paired with other therapies, might enhance movement in daily activities. Evidence also indicates that using tDCS with other rehabilitation methods can be particularly beneficial. However, results vary, and not all studies show significant improvement. Still, this approach is generally safe, offering encouragement for those considering it as a treatment option. ^{2 6 7 8 9}

Who Is on the Research Team?

David A Cunningham, PhD

Principal Investigator

MetroHealth Medical Center

Are You a Good Fit for This Trial?

This trial is for stroke survivors over 21 years old with chronic upper limb hemiplegia, who can follow commands and have some finger movement. They must be medically stable, able to sit unassisted, and at least 6 months post-stroke. Excluded are pregnant individuals, those with other neurological conditions or severe pain in the affected limb, recent botox injections in the arm muscles, certain metal implants or electronic devices.

Inclusion Criteria

I can fully move and use my unaffected arm and hand.

Medically stable

I can follow complex instructions and remember things well.

Exclusion Criteria

I cannot move my hand or shoulder without severe pain.

I have seizures that are not controlled by medication.

I have a neurological condition besides a past stroke affecting my arm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive brain stimulation and neuromuscular electrical stimulation to improve hand motor control

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• electrical stimulator
• transcranial direct current stimulation

Trial Overview The study tests how non-invasive brain stimulation (tDCS) combined with functional electrical stimulation affects hand motor control in stroke patients. It explores optimal timing and delivery methods of these treatments to improve hand function.

How Is the Trial Designed?

Group I: unconventional tDCS preceding CCFES Experimental Treatment 1 Intervention

tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere

Group II: unconventional tDCS concurrent with CCFES Experimental Treatment 1 Intervention

tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere

Group III: conventional tDCS preceding CCFES Experimental Treatment 1 Intervention

tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere

Group IV: conventional tDCS concurrent with CCFES Experimental Treatment 1 Intervention

tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere

Group V: sham tDCS with CCFES Placebo Group 1 Intervention

sham tDCS preceding and concurrent with CCFES

electrical stimulator is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation (tDCS) for:

• Stroke rehabilitation
• Motor disorders

Approved in European Union as Transcranial Direct Current Stimulation (tDCS) for:

• Stroke rehabilitation
• Motor disorders

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Published Research Related to This Trial

The study involved 49 subacute stroke patients who participated in a 4-week robotic gait training program combined with transcranial direct current stimulation (tDCS), demonstrating that this combined approach is safe and feasible, with only one patient experiencing a minor side effect.

Despite improvements in gait speed and quality across all groups, the addition of tDCS targeting the leg motor cortex did not provide any additional benefits compared to robotic gait training alone or tDCS targeting the hand motor cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS does not enhance the effects of robot-assisted gait training in patients with subacute stroke. Leon, D., Cortes, M., Elder, J., et al.[2018]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Transcranial direct current stimulation (tDCS) effectively increases beta-frequency power in the brain, indicating a readiness for improved cognitive functioning, as observed in a study with 10 healthy participants.

This study is significant as it is the first to simultaneously apply tDCS while recording EEG, providing insights into the dynamic changes in brain activity during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-frequency EEG activity increased during transcranial direct current stimulation. Song, M., Shin, Y., Yun, K.[2014]

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial direct current stimulation (tDCS) significantly improves motor function in stroke patients, with notable effects from both cathodal stimulation of the unaffected hemisphere and anodal stimulation of the affected hemisphere, as shown in a study involving multiple sessions and a blinded evaluation.

Consecutive daily sessions of tDCS resulted in lasting improvements in motor function for up to two weeks after treatment, suggesting that this simple and safe technique could be an effective rehabilitation tool for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated sessions of noninvasive brain DC stimulation is associated with motor function improvement in stroke patients. Boggio, PS., Nunes, A., Rigonatti, SP., et al.[2022]

Transcranial direct current stimulation (tDCS) shows some potential in improving activities of daily living (ADLs) in stroke survivors, with a moderate effect size observed in a systematic review of 32 studies involving 748 participants.

However, the evidence for tDCS's effectiveness on upper extremity function and muscle strength is weak, and many ongoing trials may provide more clarity on its benefits in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Elsner, B., Kugler, J., Pohl, M., et al.[2023]

Transcranial direct current stimulation (tDCS) shows potential in enhancing rehabilitation and improving motor function after a stroke, likely by correcting imbalances in brain activity between the two hemispheres.

While recent trials have shown promising results, more research is needed to establish the best stimulation methods before tDCS can be officially recommended for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Non-invasive direct current stimulation of the brain: a new technique for stroke rehabilitation]. Figlewski, K., Andersen, H.[2018]

A study involving 24 rats showed that 500 μA cathodal transcranial direct current stimulation (tDCS) applied for 10 days was safe, with no adverse effects on motor functions, learning, or memory.

The treatment did not cause any significant changes in brain morphology, neurotransmitter levels, or overall organ health, indicating that this level of tDCS is safe for use in research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A safety study of 500 μA cathodal transcranial direct current stimulation in rat. Zhang, K., Guo, L., Zhang, J., et al.[2020]

In a study involving 10 chronic stroke patients, bihemispheric transcranial direct current stimulation (tDCS) combined with therapy led to significant improvements in motor function, with an average increase of 8.2 points on the Upper-Extremity Fugl-Meyer scale after two 5-day treatment periods.

The first treatment period showed a larger improvement (5.9 points) compared to the second period (2.3 points), indicating that while tDCS is effective, the benefits from multiple sessions may not increase linearly, which is important for future rehabilitation studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined central and peripheral stimulation to facilitate motor recovery after stroke: the effect of number of sessions on outcome. Lindenberg, R., Zhu, LL., Schlaug, G.[2021]

Transcranial direct current stimulation (TDCS) is a noninvasive brain stimulation technique that can help in understanding brain function and may aid in the recovery of patients after a stroke.

TDCS has the potential to enhance neuroplasticity, which is crucial for stroke recovery, by modulating brain activity and facilitating rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in stroke recovery. Schlaug, G., Renga, V., Nair, D.[2022]

Transcranial direct current stimulation (tDCS) significantly improves motor recovery in stroke patients, with effect sizes of 0.26 for upper limb and 0.47 for lower limb functions based on a meta-analysis of 29 studies involving 664 subjects.

Chronic stroke patients showed notable improvements in upper limb function after tDCS, while subacute stroke patients experienced more significant benefits for lower limb function, indicating that the timing and parameters of tDCS treatment are crucial for optimizing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Therapeutic Effects of Transcranial Direct Current Stimulation on Upper and Lower Limb Recovery of Stroke Patients with Motor Dysfunction: A Meta-Analysis. Bai, X., Guo, Z., He, L., et al.[2020]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial direct current stimulation (tDCS) using a new montage improved the detection of right-hand motor imagery in 4 out of 5 healthy volunteers when applied for 10 minutes at the highest current density over the right-hand motor area.

While changes in EEG band power were not directly linked to improved classification accuracy, the study suggests that tDCS can influence different motor areas, indicating potential for enhancing motor neurorehabilitation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tDCS stimulation of motor cortex and cerebellum on EEG classification of motor imagery and sensorimotor band power. Angulo-Sherman, IN., Rodríguez-Ugarte, M., Sciacca, N., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3600193/

Transcranial Direct Current Stimulation in Stroke Rehabilitation Over the past few years, the potential therapeutic benefit of tDCS for improvement of cerebral function after stroke has also been reported [22–28].

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33175411/

Transcranial direct current stimulation (tDCS) for improving ... AUTHORS' CONCLUSIONS: There is evidence of very low to moderate quality on the effectiveness of tDCS versus control (sham intervention or any ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1474442225000444

Safety and efficacy of transcranial direct current stimulation ... tDCS at doses of 2 mA or 4 mA, in addition to mCIMT, did not lead to further reduction in motor impairment in patients 1–6 months after stroke, but it was safe, ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-017-0301-7

Transcranial direct current stimulation (tDCS) for improving ... Comparing different forms of tDCS shows that cathodal tDCS is the most promising treatment option to improve ADL capacity in people with stroke.

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1586685/full

Comparison of the effects of transcranial direct current ... This study employs network meta-analysis to assess the efficacy of transcranial direct current stimulation (tDCS) combined with different rehabilitation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5389927/

Safety Review of transcranial Direct Current Stimulation in ... Only 11.62% of published papers reported the occurrence of tDCS adverse effects in stroke patients. The most common was itching (70%), followed by burning ...

7. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(25)00044-4/abstract

Safety and efficacy of transcranial direct current stimulation ... We aimed to evaluate the safety and efficacy of three doses of tDCS in combination with modified constraint-induced movement therapy (mCIMT) in ...

8. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.113.001687

Safety and Efficacy of Transcranial Direct Current ... Our data indicate that transcranial direct current stimulation exerts a measurable neuroprotective effect in the acute phase of stroke. However, ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28279641/

Safety and tolerability of transcranial direct current stimulation ... Our phase I safety study supports that single session of bihemispheric tDCS with current up to 4 mA is safe and tolerable in stroke patients.